WO2009119386A1 - Fil-guide - Google Patents

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Publication number
WO2009119386A1
WO2009119386A1 PCT/JP2009/055184 JP2009055184W WO2009119386A1 WO 2009119386 A1 WO2009119386 A1 WO 2009119386A1 JP 2009055184 W JP2009055184 W JP 2009055184W WO 2009119386 A1 WO2009119386 A1 WO 2009119386A1
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WO
WIPO (PCT)
Prior art keywords
coil
wire
guide wire
end side
distal end
Prior art date
Application number
PCT/JP2009/055184
Other languages
English (en)
Japanese (ja)
Inventor
英雄 佐藤
英紀 藤曲
文彦 毛利
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to US12/933,249 priority Critical patent/US8360996B2/en
Priority to JP2010505556A priority patent/JP5489983B2/ja
Publication of WO2009119386A1 publication Critical patent/WO2009119386A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09016—Guide wires with mandrils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip

Definitions

  • the present invention relates to a guide wire, particularly a guide wire used when a catheter is introduced into a body cavity such as a blood vessel or a bile duct.
  • catheters have been introduced into blood vessels for examination and treatment of heart diseases and the like.
  • a guide wire is inserted into the catheter, and the distal end of the guide wire is advanced.
  • the distal end of the guide wire reaches the target site, and then the catheter is guided to the target site.
  • the proximal part of the guide wire Pushing ability and torque transmission ability (which are collectively referred to as “operability”), kink resistance (bending resistance), and the like are required, in which the force when pushed in is reliably transmitted to the tip portion.
  • the tip part of the guide wire is shaped with a finger or the like in accordance with the shape of the branch part. Such work is called reshaping.
  • a desired branch cannot be selected with the conventional preformed angle type or J type tip shape. For this reason, the tip of the guide wire is often inserted after being formed into a desired shape. If the shape still does not fit, remove the guide wire from the catheter and shape it again.
  • a reshaped guide wire for example, a superelastic core material, a reshape member fixed near the front end portion of the core material, a front end portion of the core material and a reshape member are covered.
  • a guide wire having a coil formed by spirally forming an element wire has been proposed (see, for example, Patent Document 1).
  • the coil is also fixed in the vicinity of the tip of the core member together with the reshaping member.
  • Such a guide wire can be reshaped at the tip by the action of the reshaping member.
  • the reshaping member disclosed in Patent Document 1 is called a shaping ribbon because the cross section is rectangular.
  • This shaping ribbon is made of a material that is easily plastically deformed, such as stainless steel.
  • the flexibility (bending rigidity) of the superelastic core material and the flexibility (bending rigidity) of the shaping ribbon are greatly different. Stress is generated due to the difference in flexibility (flexural rigidity). When this stress is concentrated, the shaping ribbon is bent in the vicinity of the joint, and the function as a guide wire is impaired.
  • the guide wire described in Patent Document 1 includes a coil in which a strand is formed in a spiral shape, and the pitch of the strand is different on both sides of the above-described joint portion.
  • the pitch of the strands is coarser on the distal end side than the joint portion, and on the other hand, the pitch of the strands is closer on the proximal end side than the joint portion. For this reason, such a difference in the pitch of the strands in the coil acts in a direction that further promotes the stress caused by the difference in flexibility (bending rigidity) between the core material and the shaping ribbon.
  • An object of the present invention is to provide a highly reliable guide wire having reduced reshapability and operability by reducing stress concentration caused by a reshapable member.
  • the present invention provides: A flexible wire body; A reshapable wire having a part of the proximal end fixed to the distal end side of the wire main body and an extending portion extending in a distal direction from the distal end of the wire main body at a part of the distal end side; A guide wire that is installed so as to cover the distal end side of the wire body and the wire, and includes a coil formed by forming a strand in a spiral shape, In the coil, the bending rigidity of the coil itself at the distal end portion located at a position corresponding to the extending portion is greater than the bending rigidity of the coil itself at the proximal end portion located at the proximal end position from the distal end portion.
  • the bending rigidity of the distal end portion of the coil itself is larger than that of the proximal end portion, the difference between the bending rigidity of the coil itself is utilized to join the wire and the wire body. Local concentration of stress on the part is suppressed, and the wire can be prevented from bending. As a result, there is no possibility that the guide wire is bent and cannot be used, and the guide wire is highly reliable with both excellent reshaping and operability.
  • the difference in the bending rigidity of the coil is caused by a difference in the pitch of the strands between the distal end side portion and the proximal end side portion.
  • the difference in bending rigidity between the distal end side portion and the proximal end side portion of the guide wire can be easily reduced by simply providing a difference in the pitch of the strands, and the reliability of the guide wire is increased. Can do.
  • the tip side portion of the coil is formed by forming the strands into a multiple spiral shape
  • the base end side portion of the coil is formed by forming the strands into a single or multiple spiral shape
  • the difference in the bending rigidity of the coil is caused by a difference in hardness of the wire itself between the distal end side portion and the proximal end side portion.
  • a difference in bending rigidity between the distal end portion and the proximal end portion of the guide wire can be easily achieved by simply applying a hardness difference to the element wire, such as annealing, on a part of the coil. Therefore, the reliability of the guide wire can be improved.
  • the difference in hardness of the strand itself is caused by a difference in annealing conditions applied to the strand between the distal end portion and the proximal end portion.
  • the difference in bending rigidity between the distal end side portion and the proximal end side portion of the guide wire can be easily alleviated only by partially changing the annealing treatment conditions applied to the coil. Reliability can be increased.
  • the bending rigidity of the coil itself in the distal end side portion has a portion that gradually decreases from the proximal end side toward the distal end side.
  • the bending rigidity of the entire guide wire can also be reduced toward the distal end without an abrupt difference in rigidity, so that the flexibility at the most advanced portion can be particularly increased while preventing the bending of the wire. For this reason, when the guide wire is inserted into the blood vessel, the insertion operation can be performed safely without damaging the blood vessel wall.
  • the difference in bending rigidity of the coil is set to complement the difference between the bending rigidity of the extending portion of the wire and the bending rigidity of the portion where the wire and the wire body overlap. It is preferable. Thereby, the concentration of stress generated at the joint between the wire and the wire main body is more reliably suppressed, and the bending of the wire can be reliably prevented.
  • the guide wire has a uniform bending rigidity as a whole or a slightly flexible distal end, so that it can be easily inserted into a blood vessel and has high operability.
  • the said wire has comprised flat form or prismatic shape.
  • the cross-sectional shape of the wire becomes a rectangle, it is easier to bend in the long side direction of the rectangle than in the short side direction, and it is easy to define the direction of reshaping of the wire.
  • the cross-sectional shape of the wire when compared with a circular cross-sectional shape, it has the same cross-sectional area and has the same tensile strength, but it can ensure flexibility in the long side direction.
  • follow-up deformability when acting is improved.
  • the length of the extended portion of the wire is preferably 0.5 to 1 times the length of the portion other than the extended portion.
  • the length of the extending portion in the wire is preferably 5 to 20 mm.
  • the said coil is being fixed to the part with which the said wire and the said wire main body overlap with the fixing material.
  • the wire is fixed to the wire main body at two positions of a distal end portion and a base end portion in a portion where the wire rod and the wire main body overlap.
  • the wire material and the wire body are fixed in place of the entire overlapping part, so that the mechanical properties of the overlapping part are characteristics that combine the characteristics of the wire body and the wire material. It becomes.
  • the mechanical properties of the overlapping portions are both the reshaping property of the wire and this superelasticity. It becomes.
  • a guide wire having such a portion is easy to be inserted into a blood vessel, and has excellent branching selectability (excellent operability) at a branching portion of the blood vessel.
  • FIG. 1 is a longitudinal sectional view showing a first embodiment of the guide wire of the present invention.
  • FIG. 2 is a longitudinal sectional view showing a second embodiment of the guide wire of the present invention.
  • FIG. 3 is a longitudinal sectional view showing a third embodiment of the guide wire of the present invention.
  • FIG. 4 is a longitudinal sectional view showing a fourth embodiment of the guide wire of the present invention.
  • FIG. 5 is a longitudinal sectional view showing a fifth embodiment of the guide wire of the present invention.
  • FIG. 1 is a longitudinal sectional view showing a first embodiment of the guide wire of the present invention.
  • base end the right side in FIG. 1
  • tip the left side
  • FIG. 1 for the sake of easy understanding, the length direction of the guide wire is shortened and the thickness direction of the guide wire is exaggerated, and the ratio between the length direction and the thickness direction is schematically illustrated. It is very different from the actual one.
  • a guide wire 1 shown in FIG. 1 is a catheter guide wire used by being inserted into a catheter.
  • the guide body 1 mainly includes a wire main body (core wire) 2 and a part on the proximal end side is a wire main body 2.
  • a shapeable ribbon (wire) 3 that can be reshaped, and is fixed to the distal end side (small diameter portion 24) of the wire body 2 so that a part of the distal end side extends in the distal direction from the distal end of the wire body 2;
  • the spiral coil 4 provided so as to cover the shaping ribbon 3.
  • the wire body 2 is preferably made of a metal material. As shown in FIG. 1, the wire body 2 has a relatively large outer diameter 20 and is positioned closer to the distal end than the main body 20, and the outer diameter gradually decreases in the distal direction.
  • the portion of the wire body 2 on the tip side from the first taper portion 21 is inserted through the substantially central portion inside the coil 4.
  • a portion of the wire body 2 on the tip side from the first taper portion 21 is inserted in a non-contact manner with the inner surface of the coil 4.
  • a part of the base end side of the coil 4 may be in contact with the wire body 2.
  • Examples of the metal material constituting the wire body 2 include stainless steel and Ni—Ti alloy.
  • the rigidity of the wire body 2 can be gradually decreased toward the distal end direction, and the insertion operability is improved and the bending is prevented. be able to.
  • the wire body 2 can be formed of a single material such as stainless steel or a Ni—Ti alloy over its entire length, but can also be formed by combining different materials.
  • the main body portion 20 (base end side portion) is made of a relatively high rigidity material such as stainless steel, and the front end side of the main body portion 20, that is, in the illustrated embodiment, the first taper portion 21 and the intermediate portion 22 are formed.
  • the second taper portion 23 and the small diameter portion 24 are preferably made of a material having a lower rigidity than stainless steel such as a Ni—Ti alloy and exhibiting a wide elasticity such as superelasticity.
  • the combination of different materials in the wire body 2 is not limited to the above, and can be appropriately selected according to the purpose.
  • at least one of the intermediate portion 22, the second taper portion 23, and the small diameter portion 24 can be made of stainless steel in order to improve shape retention when reshaped.
  • the same material such as Ni—Ti alloy may be used, and the rigidity characteristics of the main body 20 and the front end portion of the main body 20 may be different. That is, the main body 20 may be higher in material rigidity than the front end portion of the main body 20.
  • the shaping ribbon 3 is arranged at the tip of the wire body 2 such that a part of the tip side extends from the tip of the wire body 2 in the tip direction. Further, the shaping ribbon 3 is arranged substantially parallel to the wire body 2, and a part of the proximal end side overlaps with the portion of the small diameter portion 24 of the wire body 2, so that the second taper portion 23 It is fixed on the surface.
  • a portion of the shaping ribbon 3 that is located on the distal end side and protrudes toward the distal end side from the distal end of the wire main body 2 is referred to as an “extension portion 31”, whereas it is located on the proximal end side and overlaps with the wire main body 2. This part is called “overlapping part 32”.
  • the presence of the shaping ribbon 3 makes it possible to perform the above-described reshape (shape shaping) easily and reliably. That is, when a doctor or the like reshapes the tip of the guide wire 1 with fingers, the shaping ribbon 3 is plastically deformed to form a desired shape and maintain the shape. Demonstrate.
  • reshapable means that the shape can be maintained by bending the shaping ribbon 3 into a desired shape.
  • the shaping ribbon 3 is fixed to the wire body 2 at the distal end and the proximal end of the overlapping portion 32.
  • the fixing method is not particularly limited, but in the case of the present embodiment, the fixing method is fixed by a fixing material 33 such as solder (brazing material).
  • solder solder
  • a guide wire 1 has mechanical characteristics that increase reshapability as it goes in the distal direction, and conversely increase super elasticity as it goes in the proximal direction.
  • Such a guide wire 1 is easy to insert into a blood vessel, and has excellent branching ease of selection (excellent operability) at the branching portion of the blood vessel.
  • the length of the extending portion 31 is preferably about 0.5 to 1 times the length of the portion other than the extending portion 31 (the overlapping portion 32), and 0.7 to 0 More preferably, it is about 9 times.
  • the guide wire 1 is particularly excellent in insertion into a blood vessel and ease of selection of a branch of the blood vessel.
  • the length of the extending portion 31 is preferably about 5 to 20 mm, and more preferably about 10 to 15 mm.
  • the operability is particularly high, and thereby the guide wire 1 with high safety can be obtained.
  • the shaping ribbon 3 is made of, for example, a plastically deformable (reshapable) material such as stainless steel, so that the above-described reshape (shaping) can be performed more easily and reliably.
  • a plastically deformable (reshapable) material such as stainless steel
  • the length of the shaping ribbon 3 is not particularly limited, but usually it is preferably about 0.5 to 4.0 cm, more preferably about 1.5 to 3.0 cm.
  • the shaping ribbon 3 is particularly flexible (soft) and can be reshaped easily.
  • the shaping ribbon 3 has a flat plate shape or a prismatic shape as shown in the cross-sectional view along the line AA in FIG.
  • bending in the long side direction (vertical direction in FIG. 1) of the rectangle is easier than bending in the short side direction, and the direction of reshaping is
  • the cross-sectional shape has the same cross-sectional area compared to a circular one, and the tensile strength is comparable, but flexibility in the long side direction can be secured. The follow-up deformability when stress is applied is improved.
  • the cross-sectional shape of the shaping ribbon 3 may be a square such as a square, a rectangle, or a trapezoid.
  • Such a flat plate-like or prismatic portion may be present in a part of the shaping ribbon 3.
  • the shaping ribbon 3 may have a portion where the cross-sectional shape changes (area decreases or increases) even if the cross-sectional shape is constant over the entire length thereof.
  • At least a part of the shaping ribbon 3 may be provided with a layer of the X-ray opaque material as described above.
  • X-ray contrast property is acquired in the thin diameter part 24, and it can insert in in vivo, confirming the position of a front-end
  • the coil 4 includes a spiral first coil 41 installed on the distal end side of the wire body 2 and a spiral second coil 42 connected (joined) to the proximal end side of the first coil 41. Yes.
  • the 1st coil 41 is located so that the shaping ribbon 3 and the small diameter part 24 may be covered almost entirely.
  • the second coil 42 is located so as to cover almost the entire intermediate portion 22.
  • the first coil 41 has a dense pitch part 411 in which the strands are wound relatively densely and a sparse pitch part 412 in which the strands are relatively loosely wound.
  • the dense pitch portion 411 is formed at a position corresponding to the extending portion 31 of the shaping ribbon 3, while the sparse pitch portion 412 is formed at a position corresponding to the overlapping portion 32 described above.
  • the extending part 31 inside the dense pitch part 411 is composed of only the shaping ribbon 3, the bending rigidity is relatively small.
  • the overlapping portion 32 includes the shaping ribbon 3 and the wire body 2, the bending rigidity is relatively large.
  • the coil 4 provided so as to cover the shaping ribbon 3 and the tip of the wire body 2 is provided with a function for solving the above-mentioned problems.
  • the dense pitch portion 411 has a higher bending stiffness than the sparse pitch portion 412, and therefore the difference in bending stiffness of the coil 4 is used to extend the pitch.
  • the difference in bending rigidity between the protruding portion 31 and the overlapping portion 32 is reduced.
  • the local concentration of the stress with respect to the junction part of the shaping ribbon 3 and the wire main body 2 is suppressed, and it can prevent that the shaping ribbon 3 bends.
  • the guide wire 1 is not likely to be bent and cannot be used, and the guide wire 1 becomes highly reliable.
  • the strands are formed in a spiral shape, and the spiral portions are densely arranged without a gap in a state where no external force is applied. Further, the sparse pitch portion 412 is arranged so that a gap is formed in the spiral portion in a state where the strand is formed in a spiral shape and no external force is applied.
  • the difference between the wire pitch P 1 in the dense pitch portion 411 and the wire pitch P 2 in the sparse pitch portion 412 is appropriately set according to the difference in bending rigidity between the extending portion 31 and the overlapping portion 32.
  • the difference between the pitch P 1 and the pitch P 2 is that the difference in bending rigidity of the coil 4 itself due to this pitch difference is the difference in bending rigidity between the extension portion 31 and the overlapping portion 32. It is preferable to set so as to complement. As a result, the concentration of stress generated in the joint portion described above is more reliably suppressed, and the bending of the shaping ribbon 3 can be reliably prevented.
  • the pitch P 1 of the strands in the dense pitch portion 411 and the pitch P 2 of the strands in the sparse pitch portion 412 are distances between the centers of adjacent strands, as shown in FIG.
  • This condition is preferably X / when the bending rigidity of the entire guide wire 1 corresponding to the extended portion 31 is X and the bending rigidity of the entire guide wire 1 corresponding to the overlapping portion 32 is Y.
  • the relationship that Y is about 0.7 to 1, more preferably about 0.8 to 1 is satisfied.
  • the guide wire 1 has a uniform bending rigidity as a whole or is somewhat flexible at the distal end side, so that it can be easily inserted into a blood vessel and has high operability. .
  • the guide wire 1 of the distal portion and the proximal end side can be easily relaxed, and the reliability of the guide wire 1 can be increased.
  • the second coil 42 is connected and fixed to the proximal end side of the first coil 41.
  • the arrangement and fixing method of both coils are not particularly limited, but in this embodiment, they are arranged so that the proximal end portion of the first coil 41 and the distal end portion of the second coil 42 abut each other.
  • the first coil 41 and the second coil 42 each have a circular cross section of the strand.
  • the present invention is not limited to this, and the cross section of the strand is, for example, elliptical, It may be a quadrangle (particularly a rectangle).
  • the diameter (thickness) of the strand which comprises them by the 1st coil 41 and the 2nd coil 42 differs, and, thereby, the pitch of a helix also differs, but these are the same It may be.
  • first coil 41 and the second coil 42 may have different conditions such as the material of the wire, the cross-sectional shape, and the outer diameter / inner diameter of the coil.
  • the coil 4 is divided into the first coil 41 and the second coil 42, but these may be one coil.
  • the base end of the second coil 42 is fixed to the base end side of the intermediate portion 22 of the wire body 2.
  • the fixing method is not particularly limited, but in the case of the present embodiment, the fixing method is fixed by a fixing material 51 such as solder (brazing material).
  • Other fixing methods include welding, adhesion with an adhesive, and the like.
  • the tip of the first coil 41 is fixed to the tip of the shaping ribbon 3.
  • this fixing method is not particularly limited, in the case of the present embodiment, it is fixed by a fixing material 53 such as solder (brazing material).
  • proximal end surface of the fixing material 51 and the distal end surface of the fixing material 53 are rounded in order to prevent damage to the inner wall of the blood vessel.
  • the surface (particularly the outer surface) of the coil 4 (the first coil 41 and the second coil 42) is entirely or partially covered with a coating (not shown) made of a hydrophilic material or a hydrophobic material. Is preferred. Thereby, the guide wire 1 can be inserted more smoothly.
  • Such a film can have various modes depending on the purpose. For example, a mode in which the entire outer surfaces of the first coil 41 and the second coil 42 are covered with a lubricious hydrophobic coating, only a predetermined length on the tip side of the first coil 41 is covered with a lubricious hydrophobic coating, and the first An aspect in which the other portions of the coil 41 and the second coil 42 are covered with a hydrophilic coating, the coating does not exist only for a predetermined length on the tip side of the first coil 41, and other portions of the first coil 41 and the second coil 42 For example, the portion may be covered with a hydrophilic film or a hydrophobic film.
  • hydrophilic material constituting the coating examples include cellulose-based polymer materials, polyethylene oxide-based polymer materials, and maleic anhydride-based polymer materials (for example, maleic anhydride such as methyl vinyl ether-maleic anhydride copolymer). Copolymer), acrylamide polymer (for example, polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA) block copolymer), water-soluble nylon, polyvinyl alcohol and the like.
  • cellulose-based polymer materials examples include polyethylene oxide-based polymer materials, and maleic anhydride-based polymer materials (for example, maleic anhydride such as methyl vinyl ether-maleic anhydride copolymer). Copolymer), acrylamide polymer (for example, polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA) block copolymer), water-soluble nylon, polyvinyl alcohol and the like.
  • PGMA-DMAA poly
  • hydrophobic material which comprises a film
  • fluororesins such as polytetrafluoroethylene, a silicone type material, etc. are mentioned, for example.
  • a film may be formed on the surface of the wire body 2.
  • FIG. 2 is a longitudinal sectional view showing a second embodiment of the guide wire of the present invention and a graph schematically showing the bending rigidity of each part.
  • base end the right side in FIG. 2
  • tip the left side
  • FIG. 2 for the sake of easy understanding, the length direction of the guide wire is shortened, the thickness direction of the guide wire is exaggerated, and the ratio between the length direction and the thickness direction is schematically illustrated. It is very different from the actual one.
  • This embodiment is the same as the first embodiment except that the configuration of the first coil 41 is different.
  • the guide wire 1 shown in FIG. 2 has a wire body 2, a shaping ribbon (wire material) 3, and a coil 4 having regions where the pitches of the strands are different from each other.
  • the coil 4 shown in FIG. 2 has a first coil 41 and a second coil 42.
  • the first coil 41 is provided in a region where the strands are wound relatively densely, and a region provided on the base end side from this region and where the strands are wound relatively loosely (sparse pitch).
  • Part 412 The region where the strands are relatively densely wound is formed at a position corresponding to the extending portion 31 of the shaping ribbon 3, while the region where the strands are relatively loosely wound (sparsely).
  • the pitch portion 412) is formed at a position corresponding to the overlapping portion 32 described above. For this reason, the bending rigidity of the region in which the strands are wound relatively densely is larger than the bending rigidity of the region in which the strands are wound relatively sparsely (sparse pitch portion 412). .
  • the region where the strands are wound relatively densely is divided into three regions arranged in this order, region 411a, region 411b, and region 411c, from the tip side.
  • the strands are densely wound so that no gap is generated between the strands. For this reason, the bending rigidity of the region 411c is relatively large.
  • the strands are wound so that a gap is formed between the strands. For this reason, the bending rigidity of the region 411a is relatively smaller than that of the region 411c.
  • the wire pitch gradually increases from the region 411c side toward the region 411a side (from the proximal end side toward the distal end side). . That is, the pitch of the strands in the region 411b changes so as to smoothly connect the pitch of the strands in the region 411c and the pitch of the strands in the region 411a. For this reason, the bending rigidity of the region 411b gradually decreases from the proximal end side toward the distal end side.
  • the bending rigidity of the extension part 31 is smaller than the bending rigidity of the overlapping part 32 as in the first embodiment.
  • the magnitude relationship of this bending stiffness is shown, for example, as a broken line graph in FIG. 2 (composite bending stiffness between the wire body 2 and the shaping ribbon 3).
  • the bending rigidity of the entire guide wire 1 is shown as a solid line graph in FIG. 2, for example.
  • the bending rigidity of the entire guide wire 1 is the combined bending rigidity of the wire body 2, the shaping ribbon 3 and the coil 4.
  • the bending stiffness of the first coil 41 is obtained by subtracting the composite bending stiffness of the wire body 2 and the shaping ribbon 3 from the bending stiffness of the entire guide wire 1 and is shown as a hatched area in the graph of FIG. .
  • the portion corresponding to the extending portion 31 of the coil 4 has a portion in which the bending rigidity of the coil 4 gradually decreases toward the distal end.
  • the bending stiffness also decreases toward the tip without a steep stiffness difference.
  • the difference in bending rigidity between the extension part 31 and the overlapping part 32 is alleviated by the difference in bending rigidity between the region 411c and the sparse pitch part 412.
  • the local concentration of the stress with respect to the junction part of the shaping ribbon 3 and the wire main body 2 is suppressed, and it can prevent that the shaping ribbon 3 bends.
  • the guide wire 1 is not likely to be bent and cannot be used, and the guide wire 1 becomes highly reliable.
  • the flexibility at the most advanced portion is high. For this reason, when the guide wire 1 is inserted into the blood vessel, the insertion operation can be performed safely without damaging the blood vessel wall.
  • the diameters (thicknesses) of the coil wires of the regions 411a and 411b can be reduced (thinned).
  • the flexibility of the most advanced portion is particularly increased by gradually increasing the pitch of the strands of the region 411b from the region 411c side to the region 411a side (from the proximal end side to the distal end side). can do.
  • the bending rigidity difference between the distal end side portion and the proximal end side portion of the guide wire 1 is determined simply by appropriately setting the number of windings per unit length of the wire in the coil 4. Can be easily relaxed and the reliability of the guide wire 1 can be improved.
  • FIG. 3 is a longitudinal sectional view showing a third embodiment of the guide wire of the present invention.
  • base end the right side in FIG. 3
  • tip the left side
  • FIG. 3 for the sake of clarity, the length direction of the guide wire is shortened and the thickness direction of the guide wire is exaggerated, and the ratio between the length direction and the thickness direction is schematically illustrated. It is very different from the actual one.
  • This embodiment is the same as the first embodiment except that the configuration of the first coil 41 is different.
  • the guide wire 1 shown in FIG. 3 has a wire body 2, a shaping ribbon (wire material) 3, and a coil 4 in which a part on the tip side is a double helix.
  • the coil 4 shown in FIG. 3 has a first coil 41 and a second coil 42.
  • the 1st coil 41 has the double spiral part 413 in which the strand is wound doubly, and the single spiral part 414 in which the strand is wound single.
  • the double spiral portion 413 is formed at a position corresponding to the extending portion 31 of the shaping ribbon 3, while the single spiral portion 414 is formed in the overlapping portion 32 where the shaping ribbon 3 and the wire body 2 overlap. It is formed in the corresponding position.
  • the double helix part 413 and the s single helix part 414 are formed so that the pitches of the strands are substantially equal.
  • the extending portion 31 is composed of only the shaping ribbon 3, the bending rigidity is relatively small compared to the overlapping portion 32.
  • the double helix part 413 has a larger bending rigidity of the coil itself due to the larger number of windings of the strands per unit length than the single helix part 414.
  • the difference of the bending rigidity between the extension part 31 and the duplication part 32 mentioned above is relieved using the difference in the bending rigidity of this coil.
  • the local concentration of the stress with respect to the junction part of the shaping ribbon 3 and the wire main body 2 is suppressed, and it can prevent that the shaping ribbon 3 bends.
  • the guide wire 1 is not bent and difficult to use, and the operability is high.
  • the double helix part 413 is composed of an outer helix part 413a located outside and an inner helix part 413b located inside. Since the inner spiral portion 413b terminates at the distal end of the overlapping portion 32, that is, the base end of the extending portion 31, the difference in bending rigidity between the extending portion 31 and the overlapping portion 32 is alleviated. .
  • the strands of the outer spiral portion 413a and the inner spiral portion 413b are both tightly wound, but there may be a gap between both or one strand.
  • the double helix portion 413 is wound with a double wire
  • the single helix portion 414 is wound with a single wire.
  • the present invention is not limited to this. That is, it is only necessary that the number of windings of the strands in the double spiral portion 413 is larger than the number of windings of the strands in the single spiral portion 414.
  • the strands may be wound twice.
  • 411a and 411b may be a single spiral part and 411c may be a double spiral part.
  • 411a may be a single spiral portion
  • 411b may be a double spiral portion
  • 411c may be a triple spiral portion.
  • the difference between the number of windings per unit length of the strands in the double spiral portion 413 and the number of windings per unit length of the strands in the single spiral portion 414 is between the extension portion 31 and the overlapping portion 32. It is set as appropriate according to the difference in bending rigidity.
  • the difference between the number of turns per unit length of the strand in the double helix 413 and the number of turns per unit length of the strand in the single helix 414 is due to the difference in the number of turns. It is preferable that the difference in bending rigidity of the coil 4 itself is set so as to complement the difference in bending rigidity between the extending portion 31 and the overlapping portion 32. As a result, the concentration of stress generated in the joint portion described above is more reliably suppressed, and the bending of the shaping ribbon 3 can be reliably prevented.
  • the bending rigidity difference between the distal end side portion and the proximal end side portion of the guide wire 1 is determined simply by appropriately setting the number of windings per unit length of the wire in the coil 4. Can be easily relaxed and the reliability of the guide wire 1 can be improved.
  • FIG. 4 is a longitudinal sectional view showing a fourth embodiment of the guide wire of the present invention.
  • base end the right side in FIG. 4
  • tip the left side
  • FIG. 4 for the sake of easy understanding, the length direction of the guide wire is shortened and the thickness direction of the guide wire is exaggerated, and the ratio between the length direction and the thickness direction is schematically illustrated. It is very different from the actual one.
  • This embodiment is the same as the first embodiment except that the configuration of the first coil 41 is different.
  • the guide wire 1 shown in FIG. 4 has a wire body 2, a shaping ribbon (wire material) 3, and a coil 4 that has been partially annealed.
  • the coil 4 shown in FIG. 4 is obtained by subjecting a portion corresponding to the overlapping portion 32 to a partial annealing process.
  • the portion subjected to the annealing treatment is referred to as an annealing region 416.
  • the portion corresponding to the extending portion 31 of the coil 4 is not annealed.
  • this region is referred to as a non-annealed region 415.
  • the annealing treatment is a heat treatment in which the metal material is heated to an appropriate temperature and then gradually cooled. Generally, hardening and stress accompanying processing remain in the metal material. When such a metal material is annealed, lattice defects in the metal structure are reduced and the metal structure is homogenized, so that the work hardening and residual stress described above are reduced. As a result, the metal material is softened by the annealing process.
  • the annealing region 416 located on the proximal end side of the coil 4 has a lower hardness of the wire itself of the coil 4 than the non-annealing region 415 located on the distal end side.
  • the bending rigidity of the coil itself is relatively smaller than that in the non-annealing region 415.
  • the bending rigidity of the coil itself is relatively larger than that in the annealed region 416.
  • the extending portion 31 has a relatively small bending rigidity compared to the overlapping portion 32.
  • the difference in bending rigidity between the extension part 31 and the overlapping part 32 described above is reduced by using the difference in bending rigidity provided in the coil 4. .
  • the local concentration of the stress with respect to the junction part of the shaping ribbon 3 and the wire main body 2 is suppressed, and it can prevent that the shaping ribbon 3 bends.
  • the guide wire 1 is not likely to be bent and cannot be used, and the guide wire 1 becomes highly reliable.
  • the annealing conditions applied to the annealing region 416 are appropriately set according to the difference in bending rigidity between the extension portion 31 and the overlapping portion 32.
  • the annealing conditions applied to the annealing region 416 include the hardness difference of the wire itself between the annealing region 416 and the non-annealing region 415 caused by this annealing, and the bending rigidity of the coil itself due to this hardness difference.
  • the difference is preferably set so as to complement the difference in bending rigidity between the extending portion 31 and the overlapping portion 32. As a result, the concentration of stress generated in the joint portion described above is more reliably suppressed, and the bending of the shaping ribbon 3 can be reliably prevented.
  • the difference in bending rigidity between the distal end side portion and the proximal end side portion of the guide wire 1 can be easily reduced by simply performing an annealing process on a part of the coil 4, and the guide The reliability of the wire 1 can be improved.
  • FIG. 5 is a longitudinal sectional view showing a fifth embodiment of the guide wire of the present invention.
  • base end the right side in FIG. 5
  • tip the left side
  • FIG. 5 for the sake of easy understanding, the length direction of the guide wire is shortened, the thickness direction of the guide wire is exaggerated, and the ratio between the length direction and the thickness direction is schematically illustrated. It is very different from the actual one.
  • This embodiment is the same as the first embodiment except that the configuration of the first coil 41 is different.
  • the guide wire 1 shown in FIG. 5 has a wire body 2, a shaping ribbon (wire) 3, and a coil 4 that has been annealed.
  • the annealing amount associated with the annealing treatment applied to the portion corresponding to the overlapping portion 32 is larger than the annealing amount associated with the annealing treatment applied to the portion corresponding to the extending portion 31.
  • An annealing treatment is applied.
  • a portion corresponding to the overlapping portion 32 of the coil 4 is referred to as a large annealing region 418
  • a portion corresponding to the extending portion 31 is referred to as a small annealing region 417.
  • the amount of annealing indicates the degree of annealing of the coil 4 accompanying the annealing treatment.
  • the difference in the amount of annealing described above is due to the difference in the amount of heat applied to the small annealing region 417 and the large annealing region 418.
  • the small annealing region 417 has a higher hardness of the wire 4 of the coil 4 than the large annealing region 418. Yes. For this reason, the bending annealing of the coil itself is relatively larger in the small annealing region 417 than in the large annealing region 418.
  • the bending between the extension portion 31 and the overlapping portion 32 described above is made using the difference in bending rigidity provided in the coil 4.
  • the difference in stiffness is relaxed.
  • the local concentration of the stress with respect to the junction part of the shaping ribbon 3 and the wire main body 2 is suppressed, and it can prevent that the shaping ribbon 3 bends.
  • the guide wire 1 is not likely to be bent and cannot be used, and the guide wire 1 becomes highly reliable.
  • the conditions for annealing applied to the small annealing region 417 and the large annealing region 418 are appropriately set according to the difference in bending rigidity between the extending portion 31 and the overlapping portion 32.
  • the annealing conditions to be applied to the small annealing region 417 and the large annealing region 418, respectively, are the hardness difference of the wire itself between the small annealing region 417 and the large annealing region 418 caused by this annealing, and this hardness.
  • the difference in bending rigidity of the coil itself due to the difference is preferably set so as to complement the difference in bending rigidity between the extending portion 31 and the overlapping portion 32.
  • the difference in bending rigidity between the distal end portion and the proximal end portion of the guide wire 1 can be easily reduced by merely making the annealing treatment applied to the coil 4 partially different.
  • the reliability of the guide wire 1 can be improved.
  • each part which comprises a guide wire is a thing of arbitrary structures which can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.
  • the guide wire of the present invention may be a combination of any two or more of the configurations of the respective embodiments.
  • the bending rigidity of the distal end side portion and the proximal end side portion of the coil is increased by partially welding the coil wires (for example, laser welding or electron beam welding). And a method of partially forming a reinforcing layer for reinforcing the coil on the surface of the coil.
  • the guide wire of the present invention has a flexible wire main body, a part on the proximal end side fixed to the distal end side of the wire main body, and a part on the distal end side that extends in the distal direction from the distal end of the wire main body
  • a guide wire comprising: a re-shapeable wire having an extended portion; and a coil formed so as to cover the distal end side of the wire body and the wire, and formed by forming a strand in a spiral shape, In the coil, the bending rigidity of the coil itself at the distal end portion located at a position corresponding to the extending portion is larger than the bending rigidity of the coil itself at the proximal end portion located at the proximal end position from the distal end portion.
  • the guide wire of the present invention has industrial applicability.

Abstract

L'invention concerne un fil-guide pour un cathéter, lequel fil-guide est inséré, afin d'être utilisé, dans le cathéter et présente un corps de fil, un ruban de forme (matériau en forme de fil) remodelable monté de telle sorte qu'une partie du côté d'extrémité de base du ruban de forme est fixée au côté d'extrémité avant (section de petit diamètre) du corps de fil et qu'une partie du côté d'extrémité avant du ruban de forme s'étend dans le sens orienté vers l'extrémité avant du fil-guide depuis l'extrémité avant du corps de fil, et une bobine hélicoïdale installée de manière à recouvrir à la fois le côté d'extrémité avant du corps de fil et le ruban de forme. La bobine est divisée en une première bobine et une seconde bobine, la première bobine étant divisée en une section à pas fin et une section à pas grossier. La souplesse de cintrage de la section à pas fin est supérieure à celle de la section à pas grossier.
PCT/JP2009/055184 2008-03-27 2009-03-17 Fil-guide WO2009119386A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US12/933,249 US8360996B2 (en) 2008-03-27 2009-03-17 Guide wire
JP2010505556A JP5489983B2 (ja) 2008-03-27 2009-03-17 ガイドワイヤ

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2008-085015 2008-03-27
JP2008085015 2008-03-27

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WO2009119386A1 true WO2009119386A1 (fr) 2009-10-01

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JP (1) JP5489983B2 (fr)
WO (1) WO2009119386A1 (fr)

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JP2011147752A (ja) * 2009-12-25 2011-08-04 Asahi Intecc Co Ltd ガイドワイヤ
JP2012000279A (ja) * 2010-06-17 2012-01-05 Asahi Intecc Co Ltd 医療用ガイドワイヤ
JP2013000499A (ja) * 2011-06-21 2013-01-07 Asahi Intecc Co Ltd ガイドワイヤ
JP2013523282A (ja) * 2010-03-31 2013-06-17 ボストン サイエンティフィック サイムド，インコーポレイテッド 曲げ剛性プロファイルを有するガイドワイヤ
WO2013145893A1 (fr) * 2012-03-29 2013-10-03 日本ライフライン株式会社 Fil-guide médical
US8622932B2 (en) 2009-12-25 2014-01-07 Asahi Intecc Co., Ltd. Guidewire
JP5948535B1 (ja) * 2015-05-29 2016-07-06 株式会社エフエムディ 医療用ガイドワイヤ
WO2016158671A1 (fr) * 2015-03-31 2016-10-06 東レ・メディカル株式会社 Fil-guide de cathéter
JP2017521177A (ja) * 2014-07-22 2017-08-03 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． 複数の平坦部分を持つコアワイヤを有する血管内デバイス、システム及び方法
JP2018079247A (ja) * 2016-11-18 2018-05-24 テルモ株式会社 ガイドワイヤ
JP2018524086A (ja) * 2015-07-17 2018-08-30 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． 接着剤で取り付けられた成形リボンを用いる血管内装置、システム及び方法
WO2020003501A1 (fr) 2018-06-29 2020-01-02 朝日インテック株式会社 Fil-guide
WO2020003502A1 (fr) * 2018-06-29 2020-01-02 朝日インテック株式会社 Fil-guide
KR20200054276A (ko) * 2017-10-12 2020-05-19 아사히 인텍크 가부시키가이샤 가이드 와이어
JP2020137854A (ja) * 2019-02-28 2020-09-03 朝日インテック株式会社 ガイドワイヤ
JP2020533069A (ja) * 2017-09-08 2020-11-19 アクラレント インコーポレイテッドＡｃｃｌａｒｅｎｔ， Ｉｎｃ． 絡み合ったコアワイヤを有するガイドワイヤアセンブリ
JPWO2021038845A1 (fr) * 2019-08-30 2021-03-04
CN113181512A (zh) * 2021-04-28 2021-07-30 深圳市顺美医疗股份有限公司 一种先进的高扭控传导导丝及其制备方法
US11400262B2 (en) 2017-09-30 2022-08-02 Asahi Intecc Co., Ltd. Guidewire having external coil with sections of different winding pitches and resin coatings

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JP4913198B2 (ja) * 2009-10-27 2012-04-11 株式会社パテントストラ 医療用ガイドワイヤ、医療用ガイドワイヤの製造方法、医療用ガイドワイヤとマイクロカテーテルとガイディングカテーテルとの組立体、および医療用ガイドワイヤとバルーンカテーテルとガイディングカテーテルとの組立体
JP2013094343A (ja) * 2011-10-31 2013-05-20 Asahi Intecc Co Ltd ガイドワイヤ
EP3434310B1 (fr) * 2017-07-26 2023-06-21 Heraeus Medical Components, LLC Pointe élastique et procédé
JP6840644B2 (ja) * 2017-09-05 2021-03-10 株式会社東芝 半導体装置
JP6933734B2 (ja) * 2018-02-07 2021-09-08 朝日インテック株式会社 ガイドワイヤ
JP7261879B2 (ja) * 2019-06-28 2023-04-20 朝日インテック株式会社 ガイドワイヤ
GB2600976B (en) * 2020-11-13 2023-06-14 Cardiomech As Device for heart repair
WO2024044433A1 (fr) * 2022-08-26 2024-02-29 Stryker Corporation Dispositifs médicaux à bobines radio-opaques

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JP2011147753A (ja) * 2009-12-25 2011-08-04 Asahi Intecc Co Ltd ガイドワイヤ
US8622932B2 (en) 2009-12-25 2014-01-07 Asahi Intecc Co., Ltd. Guidewire
JP2011147752A (ja) * 2009-12-25 2011-08-04 Asahi Intecc Co Ltd ガイドワイヤ
JP2013523282A (ja) * 2010-03-31 2013-06-17 ボストン サイエンティフィック サイムド，インコーポレイテッド 曲げ剛性プロファイルを有するガイドワイヤ
JP2012000279A (ja) * 2010-06-17 2012-01-05 Asahi Intecc Co Ltd 医療用ガイドワイヤ
JP2013000499A (ja) * 2011-06-21 2013-01-07 Asahi Intecc Co Ltd ガイドワイヤ
WO2013145893A1 (fr) * 2012-03-29 2013-10-03 日本ライフライン株式会社 Fil-guide médical
JP2013202308A (ja) * 2012-03-29 2013-10-07 Japan Lifeline Co Ltd 医療用ガイドワイヤ
CN104023783A (zh) * 2012-03-29 2014-09-03 日本来富恩株式会社 医疗用导线
KR101844630B1 (ko) 2012-03-29 2018-04-02 니혼라이프라인 가부시키가이샤 의료용 가이드 와이어
JP2017521177A (ja) * 2014-07-22 2017-08-03 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． 複数の平坦部分を持つコアワイヤを有する血管内デバイス、システム及び方法
WO2016158671A1 (fr) * 2015-03-31 2016-10-06 東レ・メディカル株式会社 Fil-guide de cathéter
JP2016189998A (ja) * 2015-03-31 2016-11-10 東レ・メディカル株式会社 カテーテル用ガイドワイヤ
JP5948535B1 (ja) * 2015-05-29 2016-07-06 株式会社エフエムディ 医療用ガイドワイヤ
JP2018524086A (ja) * 2015-07-17 2018-08-30 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． 接着剤で取り付けられた成形リボンを用いる血管内装置、システム及び方法
JP2018079247A (ja) * 2016-11-18 2018-05-24 テルモ株式会社 ガイドワイヤ
JP7370963B2 (ja) 2017-09-08 2023-10-30 アクラレント インコーポレイテッド 絡み合ったコアワイヤを有するガイドワイヤアセンブリ
JP2020533069A (ja) * 2017-09-08 2020-11-19 アクラレント インコーポレイテッドＡｃｃｌａｒｅｎｔ， Ｉｎｃ． 絡み合ったコアワイヤを有するガイドワイヤアセンブリ
US11400262B2 (en) 2017-09-30 2022-08-02 Asahi Intecc Co., Ltd. Guidewire having external coil with sections of different winding pitches and resin coatings
KR20200054276A (ko) * 2017-10-12 2020-05-19 아사히 인텍크 가부시키가이샤 가이드 와이어
KR102445728B1 (ko) 2017-10-12 2022-09-22 아사히 인텍크 가부시키가이샤 가이드 와이어
WO2020003501A1 (fr) 2018-06-29 2020-01-02 朝日インテック株式会社 Fil-guide
JPWO2020003502A1 (ja) * 2018-06-29 2021-06-10 朝日インテック株式会社 ガイドワイヤ
JP7050920B2 (ja) 2018-06-29 2022-04-08 朝日インテック株式会社 ガイドワイヤ
CN112312954A (zh) * 2018-06-29 2021-02-02 朝日英达科株式会社 导丝
WO2020003502A1 (fr) * 2018-06-29 2020-01-02 朝日インテック株式会社 Fil-guide
JP2020137854A (ja) * 2019-02-28 2020-09-03 朝日インテック株式会社 ガイドワイヤ
JP7353043B2 (ja) 2019-02-28 2023-09-29 朝日インテック株式会社 ガイドワイヤ
JPWO2021038845A1 (fr) * 2019-08-30 2021-03-04
WO2021038845A1 (fr) 2019-08-30 2021-03-04 朝日インテック株式会社 Fil de guidage et procédé de fabrication de fil de guidage
JP7270047B2 (ja) 2019-08-30 2023-05-09 朝日インテック株式会社 ガイドワイヤ、及び、ガイドワイヤの製造方法
CN113181512A (zh) * 2021-04-28 2021-07-30 深圳市顺美医疗股份有限公司 一种先进的高扭控传导导丝及其制备方法

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US20110015618A1 (en) 2011-01-20
JP5489983B2 (ja) 2014-05-14
US8360996B2 (en) 2013-01-29

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